Capecitabine/Erlotinib Followed of Gemcitabine Versus Gemcitabine/Erlotinib Followed of Capecitabine

Sponsor
PD Dr. med. Volker Heinemann
Study ID
NCT00440167
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m², d 1, 8 , 15, q d28
  • Capecitabine — DRUG
    Capecitabine 2 x 1000 mg/m²/ d oral, d 1 - 14 followed by 7 days Pause ("Flat Dosing")
  • Erlotinib — DRUG
    Erlotinib 150 mg/d oral, daily without break

Study Details

This crossover trial is performed in advanced and metastatic pancreatic cancer not previously exposed to chemotherapy. The study compares a standard arm with gemcitabine plus erlotinib to an experimental arm with capecitabine plus erlotinib. It is the first trial of its kind to incorporate second-line treatment into the study design. Patient who fail on first-line therapy are switched to the comparator chemotherapy without erlotinib. The trial therefore not only compares two different regimens of first-line treatment, it also compares two sequential treatment strategies.

Key Dates

First listed
Feb 26, 2007
Start date
Jun 30, 2006
Status verified
Jul 2012
Primary completion
Dec 31, 2011
Completion
Dec 31, 2012

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

TTF2 [ Time Frame: approximate 6 months after first line treatment ]

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